(87 days)
The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter.
The electrodes are intended for short-term use (
The SVL-9630 electrodes consists of a pair of non sterile, hydrogel polymeric selfadhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.
The provided document is a 510(k) summary for the Survivalink SVL-9630 Disposable Polymer (Hydrogel) Multifunctional Electrode. The document states that the device is substantially equivalent to predicate devices and meets AAMI DF-39 performance standards. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information for AI/algorithm performance studies.
This document describes a medical device, which is an electrode for defibrillators and pacemakers, not an AI or algorithm-based diagnostic tool. Therefore, many of the requested fields (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to the information provided.
Based on the provided text, here's what can be extracted:
1. A table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (from AAMI DF-39) | Reported Device Performance |
|---|---|
| Specifications for single use hydrogel electrodes (AAMI DF-39) | Met all specifications. |
| Survivalink's internal specifications | Met all specifications. |
| Functioned as intended | Functioned as intended. |
Note: The specific parameters of AAMI DF-39 that were tested (e.g., impedance, adhesion, current distribution) are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. This is a physical medical device (electrode), not an algorithm. The testing would involve engineering and biocompatibility evaluations, not data sets from patients in the context of AI performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of expert consensus, is for diagnostic algorithms.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document pertains to a physical electrode, not an AI system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of diagnostic algorithms. For an electrode, ground truth would relate to its physical and electrical performance against established standards.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.